SPYROMITE 72201882Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010619075), received between Jan 13, 2020 and Dec 26, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX MONTHS AFTER A LEFT PINKY REPAIR SURGERY, WHERE A SPYROMITE WAS USED, THE PATIENT EXPERIENCED SWELLING ON THE FINGER, ON DECEMBER 2ND A REVISION SURGERY WAS PERFORMED, WHERE IT WAS FOUND EXUDATION AROUND THE TENDON SUTURE KNOT, PTERYGIUM-LIKE NECROSIS AROUND THE STAPLE FIXATION SUTURE WITH THREAD AND INFLAMMATORY HYPERPLASIA OF THE SURROUNDING TISSUE; AND THEREFORE THE SUTURES WERE REMOVED. PATIENT´S CURRENTLY FINE. AS THIS WAS NOTICED AFTER THE ORIGINAL PROCEDURE, THIS WAS FINISHED WITH THE REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED, AS THE REPORTED ONES, WERE SOLVED AFTER THE REVISION SURGERY.

  Patient problems: Hyperplasia; Swelling/ Edema

  MAUDE report 16048826 ↗
• InjuryNov 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A MAXILLOFACIAL IN MANDIBULAR CONDYLE PROCEDURE WHEN A MANDIBULAR OR ENCONDYLOMANDIBULAR PERFORATION WAS PERFORMED, AT THE TIME OF INTRODUCING THE ANCHOR, IT WAS RELEASED FROM THE HANDLE. IT WAS ADJUSTED AGAIN TO INSERT BUT NO FIXATION WAS OBTAINED IN THE BONE. THE PROCEDURE HAD TO BE COMPLETED WITH A TITANIUM ANCHOR, THERE WAS NO DELAY OR FURTHER COMPLICATIONS REPORTED. PATIENT'S CONDITION IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10908902 ↗
• MalfunctionJan 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE BROKE WHEN TURNING IT AFTER IT WAS INSERTED. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580700 ↗